Abdominal PainEFRAIMNCT01080690
Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
A study testing EGD and EUS in people with Abdominal Pain, run by Technical University of Munich at 1 site in Germany.
Trial summary
Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain. Patients with acute right side abdominal pain will be randomized in one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- EGD and EUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute right side abdominal pain
- willing participate study
Who cannot join
- acute disease
- malignancy
- other disease which might cause discomfort
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum r.d. Isar, Technical University Munich
Munich
Alexander Meining, Prof., +49 89 41400, valentin.becker@lrz.tum.de
About this study
Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.
Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.
Read more
Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
- Conditions
- Abdominal Pain
- Being tested
- EGD, EUS
- Keywords
- endosonography, right side abdominal pain, Endosonography (diagnostic value in right side abdominal pain)
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGDProcedure or surgery
Also called EGD: A standard diagnostic EGD will be performed., EUS: A standard diagnostic EUS will be performed.
In this arm EGD will be performed before EUS.
EUSProcedure or surgery
In this arm EUS will be performed before EGD.
| Study group | Role | What they receive |
|---|---|---|
| EGD | Active comparator | In this arm EGD will be performed before EUS Receives: Procedure: EGD |
| EUS | Active comparator | In this arm, EUS will be performed before EGD. Receives: Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Measured: within the first week of complaints
Secondary outcomes (1)
Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Alexander Meining, Prof., Principal investigator, II Med Dep, TU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080690
- Sponsor's protocol ID
- 01102
- Acronym
- EFRAIM
- Status last verified
- Feb 2010
- First submitted
- 27 Jan 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonography For Right Side Acute Intestinal Mal-Symptoms (EFRAIM- Study)
- ClinicalTrials.gov ID
- NCT01080690
- Acronym / sponsor ID
- EFRAIM / 01102
- Conditions
- Abdominal Pain
- Keywords
- endosonography, right side abdominal pain, Endosonography (diagnostic value in right side abdominal pain)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Endosonography (EUS) in a single setting is equivalent to the standard algorithm combining abdominal sonography, gastroscopy, endosonography in patients with acute right side abdominal pain.
Patients with acute right side abdominal pain will be randomized in one of two groups. In each group all examinations (sonography, gastroscopy, endosonography) will be performed. The study group only defines the order of the examinations. Abdominal sonography will always be performed before endoscopic procedures. In group 1, gastroscopy is first followed by endosonography. In group 2 endosonography is first followed by gastroscopy.
Two physicians will review all results of all examinations, patient charts as well as a follow up visit and establish a clinical diagnosis.
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD | Active comparator | Procedure: EGDIn this arm EGD will be performed before EUS |
| EUS | Active comparator | Procedure: EUSIn this arm, EUS will be performed before EGD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute right side abdominal pain
- willing participate study
Key exclusion criteria (3 listed)
- acute disease
- malignancy
- other disease which might cause discomfort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGDAlso: EGD: A standard diagnostic EGD will be performed., EUS: A standard diagnostic EUS will be performed.In this arm EGD will be performed before EUS. | Procedure or surgery | EGD |
| EUSIn this arm EUS will be performed before EGD. | Procedure or surgery | EUS |
Primary outcome
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS.
Time frame: within the first week of complaints
1 secondary outcome
Calculate the time and cost savings and number of procedures for endosonography alone versus the combined approach of abd. sonography, gastroscopy and endosonography.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Meining, Prof. principal investigator
II Med Dep, TU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGD and EUS in people with Abdominal Pain, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentin Becker, Dr. (+49 89 41400, valentin.becker@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield of the clinical diagnosis by EUS results alone will be compared to the yield by combined results of sonography, EGD and EUS. (time frame: within the first week of complaints). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2010.